UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027350
Receipt No. R000031327
Scientific Title A prospective study of amino acid profile index for colorectal cancer screening.
Date of disclosure of the study information 2017/05/22
Last modified on 2017/05/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A prospective study of amino acid profile index for colorectal cancer screening.
Acronym A prospective study of amino index colorectal cancer screening
Scientific Title A prospective study of amino acid profile index for colorectal cancer screening.
Scientific Title:Acronym A prospective study of amino index colorectal cancer screening
Region
Japan

Condition
Condition early colorectal neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare performance of amino index cancer screening test with fecal immunochemical test for detection of early colorectal neoplasm.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity of AICS for colorectal adenoma, intramucosal cancer and submucosal invasive cancer
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 amino index cancer screening test and fecal immunochemical test
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients who have
1)colorectal adenoma >= 20 mm
2)colorectal intramucosal cancer
3)colorectal submucosal invasive cancer
Key exclusion criteria Patients
1) with inflammatory bowel disease
2) with familial adenomatous polyposis
3) have multiple primary neoplasms
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Matsuda
Organization National Cancer Center Hospital
Division name Endoscopy division
Zip code
Address 5-1-1,tsukiji,chuo-ku,Tokyo
TEL 03-3542-2511
Email tamatsud@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takamaru
Organization National Cancer Center Hospital
Division name Endoscopy division
Zip code
Address 5-1-1,tsukiji,chuo-ku,Tokyo
TEL 03-3542-2511
Homepage URL
Email htakamar@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Institute for Inovation, Ajinomoto Co
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 15 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031327

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.